FDA Guidance for Mobile Medical Applications

Summary

This document from the U.S. Food and Drug Administration provides guidance on how the agency regulates apps requiring clearance, such as Mobile Medical Applications (MMAs) and other mobile device software functions with a clinical application.

Details

Policy for Device Software Functions and Mobile Medical Applications

Download

View article on FDA's website.

Notes

• None.

Resources

• Also see Ask a Question About Digital Health Regulatory Policies, which gives further FDA guidance on digital health in the broader sense including General Wellness products (commercial wearables).